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Completed

NCT Number: NCT04548310

Muscle Fatigue in Patients With Multiple Sclerosis

It is stated that 85% of patients with Multiple Sclerosis (MS) complain of gait disorders and 35-90% of them have fatigue. Many factors play a role in the fatigue mechanism in MS patients. Fatigue can increase the symptoms that already exist in MS patients. It is thought that fatigue caused a decrease in muscle strength, making walking worse. There are not enough studies investigating whether fatigue affects gait parameters in MS patients.

The aim of this study is to examine the effects of muscle fatigue on muscle strength, joint position sensation, and gait in MS patients.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University

Ankara, Turkey (Türkiye)

About this study

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The muscle strength, joint position sensation, gait, and fatigue will be evaluated once.

The investigators will use descriptive statistics and t-tests to compare demographic characteristics between groups and for the categorical variables chi-square. Effect of the group (MS patients or healthy controls), condition (Single task and dual-task conditions), and group × condition interaction will be compared using two-way repeated-measures ANOVA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who 18-65 years of age
  • MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month

Exclusion criteria

  • Participants who have orthopedic, vision, hearing, or perception problems

Treatment and study plan

Muscles Fatigue

Other

An exhaustion protocol that reduces knee joint flexor and extensor torque will be applied.

Primary outcomes

  1. Knee proprioception

    Time frame: 10 minutes

    Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).

  2. Knee strength

    Time frame: 20 minutes

    Knee strength will be evaluated using the isokinetic system (Cybex Norm, Humac, CA, USA).

  3. Gait

    Time frame: 5 minutes

    Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed.

    Gait symmetry values of the right and left sides are obtained within this report. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrica.

  4. Perceived Exertion

    Time frame: 1 minute

    The Borg Rating of Perceived Exertion (RPE) scale is a tool for measuring an individual's effort and exertion, breathlessness, and fatigue.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Effect of Muscle Fatigue on Strength, Joint Position Sensation, and Walking in Patients With Multiple Sclerosis

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2020
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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